The Safety and Efficacy of 5-HT3 Receptor Antagonist (Ramosetron) for the Treatment of Fecal Incontinence (SERAFI)

Seoul National University

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: Fecal Incontinence

Treatments: Drug: Ramosetron; Drug: Psyllium

Study type: Interventional

Funder types: Other

Identifiers

NCT06166615

H-2303-158-1417

Details and patient eligibility

About

This clinical trial aims to assess the effectiveness of Ramosetron compared to Psyllium, a gold standard therapy, in patients with fecal incontinence. The primary questions it seeks to answer are:

1. Does Ramosetron improve the symptoms of fecal incontinence?
2. Is Ramosetron superior to Psyllium in terms of symptom improvement and its impact on quality of life?

Participants will be randomly assigned to one of two groups, either taking Ramosetron or Psyllium for one month. They will be asked to complete a questionnaire. Researchers will then compare the Fecal Incontinence Severity Index between the Ramosetron and Psyllium groups to determine whether Ramosetron provides superior symptom relief compared to Psyllium.

Enrollment: 148 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients diagnosed with fecal incontinence (patients with 2 or more symptoms of fecal incontinence per month for at least 3 months).
2. Patients who are able to understand and comply with this study.
3. Individuals who are agreeable to being on contraception for the duration of the study.

Exclusion criteria

1. Patients who have difficulty swallowing medications
2. Patients with gastrointestinal deformities due to surgery
3. Patients with malabsorption
4. Patients with inflammatory bowel disease (IBD)
5. Patients undergoing treatment for cancer of the gastrointestinal tract
6. Patients who are allergic to the study drug
7. Patients with overflow incontinence and fecal impaction on rectal residual examination (DRE) or Bristol Stool Scale of 3 or less.
8. Patients taking medication for fecal incontinence within 1 month of study entry.
9. Pregnant or lactating women.
10. Patients with contraindications to any of the study drugs (i.e., intestinal obstruction, intestinal stones, acute abdomen, undiagnosed abdominal pain/nausea/vomiting, gastrointestinal stenosis and dysphagia, patients with megacolon syndrome, severe diabetes, etc.).
11. Patients taking an agent that is contraindicated in combination with either study drug.
12. Patients deemed by the investigator and staff to be unsuitable for participation in the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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148 participants in 2 patient groups

Pyllium group

Active Comparator group

Description:

Take 2 sachets (12 g) orally once daily. Increase or decrease the dose as needed to treat your symptoms, with a maximum daily dose of 18 grams (6 grams in the morning and 12 grams in the evening). Do not chew this medication and take it with 1 to 2 cups of water. Take it for 1 month

Treatment:

Drug: Psyllium

Ramosetron group

Experimental group

Description:

Men: 5 μg orally once daily. Increase or decrease the dose as needed based on symptoms, with a minimum daily dose of 2.5 μg and a maximum daily dose of 10 μg. Women: 2.5 μg orally once daily. Women: 2.5 μg orally once daily, titrated up or down as needed, with a maximum daily dose of 5 μg. Take it for 1 month

Treatment:

Drug: Ramosetron